» Articles » PMID: 35784493

The Medicines Intelligence Centre of Research Excellence: Co-creating Real-world Evidence to Support the Evidentiary Needs of Australian Medicines Regulators and Payers

Abstract

Regulators and payers play a pivotal role in facilitating timely and affordable access to safe and efficacious medicines. They use evidence generated from randomised clinical trials (RCTs) to support decisions to register and subsidise medicines. However, at the time of registration and subsidy approval, regulators and payers face uncertainty about how RCT outcomes will translate to real-world clinical practice. In response to this situation, medicines policy agencies worldwide have endorsed the use of real-world data (RWD) to derive novel insights on the use and outcomes of prescribed medicines. Recent reforms around data availability and use in Australia are creating unparalleled data access and opportunities for Australian researchers to undertake large-scale research to generate evidence on the safety and effectiveness of medicines in the real world. Highlighting the critical importance of research in this area, Quality Use of Medicines and Medicine Safety was announced as Australia's 10th National Health Priority in 2019. The National Health and Medical Research Council, Medicines Intelligence Centre of Research Excellence (MI-CRE) has been formed to take advantage of the renewed focus on quality use of medicines and the changing data landscape in Australia. It will generate timely research supporting the evidentiary needs of Australian medicines regulators and payers by accelerating the development and translation of real-world evidence on medicines use and outcomes. MI-CRE is developing a coordinated approach to identify, triage and respond to priority questions where there are significant uncertainties about medicines use, (cost)-effectiveness, and/or safety and creating a data ecosystem that will streamline access to Australian data to enable researchers to generate robust evidence in a timely manner. This paper outlines how MI-CRE will partner with policy makers, clinicians, and consumer advocates to leverage real-world data to co-create real-world evidence, to improve quality use of medicines and reduce medicine-related harm.

Citing Articles

ution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a oping eview protocol.

Stehlik P, Dowsett C, Camacho X, Falster M, Lim R, Nasreen S BMJ Open. 2024; 14(3):e079071.

PMID: 38508618 PMC: 10952922. DOI: 10.1136/bmjopen-2023-079071.


Can old drugs learn new tricks? Achieving registration and public subsidy listing for off-patent medicines with novel therapeutic applications.

Brett J, Bahceci D, Lipworth W, Liknaitzky P, Day R, Rodgers A Intern Med J. 2023; 53(7):1284-1287.

PMID: 37409815 PMC: 10947264. DOI: 10.1111/imj.16159.

References
1.
Pratt N, Roughead E, Ryan P, Gilbert A . Differential impact of NSAIDs on rate of adverse events that require hospitalization in high-risk and general veteran populations: a retrospective cohort study. Drugs Aging. 2009; 27(1):63-71. DOI: 10.2165/11531250-000000000-00000. View

2.
Brett J, Zoega H, Buckley N, Daniels B, Elshaug A, Pearson S . Choosing wisely? Quantifying the extent of three low value psychotropic prescribing practices in Australia. BMC Health Serv Res. 2018; 18(1):1009. PMC: 6310957. DOI: 10.1186/s12913-018-3811-5. View

3.
Lim R, Kalisch Ellett L, Semple S, Roughead E . The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021. Drug Saf. 2022; 45(3):249-257. PMC: 8933367. DOI: 10.1007/s40264-021-01144-1. View

4.
Williamson A, Tait H, El Jardali F, Wolfenden L, Thackway S, Stewart J . How are evidence generation partnerships between researchers and policy-makers enacted in practice? A qualitative interview study. Health Res Policy Syst. 2019; 17(1):41. PMC: 6466802. DOI: 10.1186/s12961-019-0441-2. View

5.
King C, Pratt N, Craig N, Thai L, Wilson M, Nandapalan N . Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set. Drug Saf. 2020; 43(8):787-795. DOI: 10.1007/s40264-020-00940-5. View